Table 1B.
Study | Food allergen | N | Age Range | Study design | Maintenance Dose | Desensitization Outcome | Long-term results | Adverse events |
---|---|---|---|---|---|---|---|---|
Meglio et al. 200850 Meglio et al. 200466 | Fluid milk | 21 | 5–10 years | Open-label, not controlled. | Up to 200 mL milk or milk-containing foods | 71% (15/21) tolerated 200 mL, 14% (3/21) reached 40–80 mL. Mean duration 201 days (range 183–234 days). | After 48–51 months, 70% in follow-up (14/20) tolerating some milk. 43% (9/14) taking milk ad lib. | Desensitization: 3/21 (14%) had mild symptoms so discontinued; 3/21 (14%) had symptoms so took a lower daily dose. Follow-up: no reactions requiring epinephrine. |
Pajno et al. 201367 | Fluid milk | 32 | 4–13 years | RCT, open-label, comparison of maintenance regimens. | 150–200 mL daily (group A) or twice weekly (group B) and milk ad lib | 100% in both groups continued maintenance, a similar frequency of allergic symptoms. | N/A | 8/15 in group A and 9/15 in group B had recorded events. |
Salmivesi et al. 201368 Paassilta et al. 201669 |
Fluid milk | 24 | 6–14 years (from initial study 2013) | RCT, placebo control, double-blind, open-label crossover. | 200 mL (6400 mg) daily | 89% (16/18) OIT desensitized, not assessed in placebo. 100% (10/10) control patients desensitized in the crossover to open-label OIT. At 12 months, 13/18 (72%) of OIT taking 6400 mg CM daily. | At 3 years, 85% OIT (including original OIT and crossover) tolerating milk daily, 58% at 7 years. | Desensitization: 100% of OIT, 80% crossover, 63% of placebo patients reported symptoms. 6–12 months maintenance: 62% had symptoms, none severe; 50% at 3 years, 19% at 7 years. |
Longo et al. 200852 | Fluid milk, then foods with milk. | 60 | 5–17 years | RCT, open-label, (OIT/milk-free diet). | 150 mL (4800 mg) then milk containing foods | At 1 year, 37% (11/30) OIT fully desensitized to 150 ml daily, 53% (16/30) OIT partially (5–15), 0 % control passed DBPCFC. | N/A | Desensitization: 4 patients required IM epinephrine. Home dosing: 2 needed epinephrine. 20% control had an adverse reaction to accidental milk. |
Morisset et al. 200751 | Fluid milk. | 57 | 1–6 years | RCT, open-label (OIT/milk-free diet). | After 6 months, 11% OIT and 40% control had positive SBPCFC (< 200 mL). | N/A | Reactions in 3 OIT, 0 control patients. | |
Martorell et al. 201170 | Fluid milk. | 60 | 2–3.5 years | RCT, open label. (OIT/milk-free diet). | 200 mL (6400 mg) daily | At 1 year, 90% milk OIT tolerant to 200 mL daily, 13% (3/23) of control passed DBPCFC. RR 7.7 for milk tolerance in OIT vs. placebo. | N/A | 80% OIT patients had ?1 reaction, all mild-moderate. Reactions with 15% (114/738) doses. |
Skpirak et al. 200853 Narisety et al. 200971 Keet et al. 201372 | Milk powder. | 20 | 6–21 years | RCT, placebo controlled, double blind, then open-label crossover. (2:1 OIT/placebo) | 500 mg daily for 13 weeks, then 7000 mg (if pass 8g DBPFC). | 23% OIT, 0 % placebo, 67% crossover OIT passed DBPCFC (8000 mg); 92% active OIT, 0% placebo, 83% of cross-over OIT tolerant to ?2540 mg. | At 5 years: 19% of 13 in follow-up tolerating unlimited milk, 31% 1 serving/day, 34% limited amounts, 16% no milk/avoiding completely. | Desensitization: reactions to 45% of 2437 doses in OIT, 11% of 1193 in placebo patients. 4 patients required epinephrine. Follow-up open-label OIT: reactions in 17% of 2465 home doses. |
Goldberg et al. 201565 | Baked milk. | 15 | 6–12 years | Open-label, uncontrolled. | Baked milk products daily as tolerated. | 21% tolerated 1.3 g baked milk OFC. Maximum tolerated dose 900 mg unheated milk. | N/A | 8/15 did not complete desensitization due to IgE-mediated reactions. 2 had anaphylaxis requiring epinephrine with home doses. |